FDA approves Novartis’ heart failure drug

The U.S. Food and Drug Administration said in a statement that the drug had been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure, and could help patients live longer and enjoy more active lives. Novartis AG on Tuesday won U.S. approval for its keenly awaited new heart failure drug Entresto earlier than expected, boosting hopes for a medicine tipped by analysts to reap billions of dollars in annual sales. Novartis is looking to Entresto to help revive its fortunes in heart medicine as the blood pressure pill Diovan – a major source of the company’s profits in the past – faces competition from generics.

Entresto, also known as LCZ696, is the first new drug in decades for helping patients whose lives are in danger because their hearts cannot pump blood efficiently.

Heart failure affects about 5.1 million people in the United States, about half of whom have the reduced ejection fraction form for which Entresto has proven suitable, where the heart muscle does not contract effectively.

The drug will be priced at $12.50 a day at the wholesale level, which Novartis said was in line with other new cardiovascular treatments.

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